Investigating the effect of photobiomodulation on pain and patient’s daily activities after surgical extraction of impacted mandibular third molar
| ISRCTN | ISRCTN80613224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80613224 |
| Secondary identifying numbers | 775/17 |
- Submission date
- 22/02/2024
- Registration date
- 26/02/2024
- Last edited
- 26/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Several postoperative complications have been reported with the surgical extraction of impacted third mandibular molars; including pain, edema, trismus, and/or functional limitation. Anti-inflammatory agents are usually prescribed for these postoperative complications. However, there are various reported side effects with the use of these drugs. In addition, their prescription is contraindicated in some patients with some conditions. Several adjunctive modalities to surgical procedures are proposed as a trial to decrease postoperative discomfort, such as the use of piezosurgery, cryotherapy, and photobiomodulation (PBM). PBM as an adjunctive modality has been widely investigated. In the literature, it has been recently observed that the combined protocols of PBM (i.e. intraoral and extraoral) are more efficient than only intraoral or extraoral protocol. In addition, it has been observed that the wavelengths used for PBM are mostly in the red and near-infrared wavelength range. To our knowledge, there is no study of PBM using a combination of different wavelengths in combined protocols (i.e. intraoral and extraoral). The study aims to evaluate the effectiveness of the single-session intraoral and extraoral PBM using a combination of different wavelengths on pain and the patient’s daily activities following the surgical extraction of the impacted third mandibular molar.
Who can participate?
Patients aged between 18 and 65 years old referred to the Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome who will undergo a surgical extraction of partially bony impacted mandibular third molar.
What does the study involve?
The study involves immediate intraoral and extraoral PBM single sessions after the surgical extraction on test group patients. While the patients of the control group are subjected to the same surgical extraction without PBM application.
What are the possible benefits and risks of participating?
The possible benefits are a significant reduction of pain, improvement of the daily social, physical, and speaking activities, and reduction of possible need for painkillers intake in the postoperative period (7 days). There are no reported risks with the PBM application.
Where is the study run from?
Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
July 2017 to December 2022
Who is funding the study?
Sapienza University of Rome (Italy)
Who is the main contact?
Prof. Umberto Romeo
umberto.romeo@uniroma1.it.
Contact information
Principal Investigator
Via Caserta 6
Rome
00161
Italy
| Phone | +390649918165 |
|---|---|
| umberto.romeo@uniroma1.it |
Public, Scientific
Via Caserta 6
Rome
00161
Italy
| Phone | +393428501864 |
|---|---|
| ahmed.mohsen@uniroma1.it |
Study information
| Study design | Single-centre randomized pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | The impact of single-session intra- and extraoral photobiomodulation on pain and patient’s daily activities after surgical extraction of impacted mandibular third molars |
| Study objectives | A single session of intraoral and extraoral photobiomodulation reduces significantly pain and improves the daily activities in patients who underwent surgical extraction of the impacted third mandibular molar than controls. |
| Ethics approval(s) |
Approved 14/09/2017, Ethics Committee of "SAPIENZA" University (Viale del Policlinico 155, Rome, 00161, Italy; +39 0649979822; comitato.etico@policlinicoumberto1.it), ref: 4687 |
| Health condition(s) or problem(s) studied | Improvement in pain and daily activities in patients who undergo surgical extraction of impacted mandibular third molar |
| Intervention | The patients are randomly divided into two groups using sealed envelopes: 1. The Test Group (TG) consists of patients subjected to immediate postoperative intra- and extraoral photobiomodulation (PBM) using laser device K-Laser Blu Dental that emit three wavelengths in combination; 445 (±5) nm, 660 (±5) nm, and 970 (±5) nm. The extraoral PBM parameters are a power of 550mW and a spot area of 5cm2. The intraoral PBM parameters are power of 200mW and spot area of 2cm2. 2. The Control Group (CG) consists of the patients not subjected to PBM. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | K-Laser Blu Dental device |
| Primary outcome measure | Pain measured using a numeric rating scale (NRS) 4 times on 0, 1, 3, and 7 days after surgical intervention |
| Secondary outcome measures | 1. Painkiller intake, defined as the number of tablets of ibuprofen 400mg, measured using a custom-made questionnaire on day 7 after surgery 2. Patient’s daily activities measured using a custom-made questionnaire on day 7 after surgery |
| Overall study start date | 25/07/2017 |
| Completion date | 07/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 22 |
| Key inclusion criteria | 1. Patients undergoing the surgical extraction of a partially bony impacted mandibular third molar 2. Normal healthy patients of both genders 3. Age age ≥ 18 years 4. No systemic disorders 5. No smoking habits 6. Absence of pericoronitis 7. No allergy to anesthetic solutions. |
| Key exclusion criteria | 1. Patients refuse to participate in the study 2. Pregnant or lactating patients 3. Patients subjected to anti-inflammatory drugs, or antibiotic therapy within 2 weeks before the surgical intervention 4. Patients with systemic disorders 5. Patients who do not complete the designed questionnaires of the study |
| Date of first enrolment | 03/01/2022 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00161
Italy
Sponsor information
University/education
Via Caserta 6
Rome
00161
Italy
| Phone | +3906499746646. |
|---|---|
| gianluca.tenore@uniroma1.it | |
| Website | https://www.uniroma1.it/it/ |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Sapienza University of Rome, Università degli Studi di Roma "La Sapienza”, Sapienza-Università di Roma, Sapienza, Uniroma1
- Location
- Italy
Results and Publications
| Intention to publish date | 15/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study are available upon request from Prof. Umberto Romeo, umberto.romeo@uniroma1.it. The data of the study is only conserved for 10 years in the Department of Oral Sciences and Maxillofacial Surgery, Sapienza University of Rome. The personal information of the participants is present only in the form of dental clinical charts protected by the privacy policy of the university. An informed consent is signed by each participant and conserved in his/her clinical chart. The individual data are deidentified by linking them only to the chart number and a new code for each study participant. The datasets generated and analyzed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 26/02/2024 | No | No |
Additional files
Editorial Notes
22/02/2024: Study's existence confirmed by the Ethics Committee of the "SAPIENZA" University.
